In the prior art, a plurality of hand-held devices have been proposed for removal of body tissue during surgical procedures. One particular surgical device includes an ultrasonically driven surgical tool handpiece that destroys or emulsifies body tissue by contact between the tissue and a vibrating tip of the surgical handpiece. These types of surgical tools are used to remove a wide range of body tissue including removal of cataracts, plaque in arteries or concretions in body tissue such as kidney stones. Included with these surgical handpiece tools are means to introduce irrigation fluid to the surgical site as well as a source of aspiration or vacuum to remove destroyed or emulsified body tissue.
In certain prior art devices, the irrigation fluid is supplied to the operative tip of the surgical tool through a channel created by placement of an infusion sleeve around the operative tip assembly of the tool. U.S. Pat. No. 4,643,717 to Cook et al. discloses an ultrasonic surgical instrument utilizing these types of sleeves. The irrigating fluid supplies a medium for facilitating emulsification of body tissue and a cooling medium to prevent overheating of the vibratory tip and subsequent damage to adjacent body tissue not intended for removal.
Various materials have been utilized in prior art infusion sleeves. U.S. Pat. No. 4,787,889 to Steppe et al. discloses a flexible sleeve made of a synthetic resin such as silicon rubber which is able to fold back or telescope when inserted through an incision. Problems with these types of prior art devices include collapsing of the flexible sleeve in the area of the wound or incision site by pressure from surrounding tissue. This collapsing of the sleeve blocks flow of irrigation fluid to the surgical site and around the vibratory surgical tip causing overheating and damage to body tissue during surgery.
Other prior art devices, as described in the above-mentioned U.S. Pat. No. 4,787,889 to Steppe et al. utilize sleeves made out of metallic materials such as stainless steel. These devices do not collapse as do flexible sleeves but also are not capable of retracting away from the operative tip of the ultrasonic tip, and, therefore, are more difficult to manipulate during surgery.
As such, a need has developed to provide an improved infusion sleeve that combines flexibility and rigidity to facilitate manipulation of the surgical tool by a surgeon while protecting tissue around the wound or incision site from damage due to overheating of the surgical tool tip. In U.S. Pat. No. 4,634,420 to Spinosa et al. an infusion sleeve is disclosed which includes ribs provided around the interior circumference of the sleeve to prevent collapse when the apparatus is inserted into an eye. U.S. Pat. No. 4,983,160 to Steppe et al. discloses an infusion sleeve made of a synthetic resin material which provides sufficient rigidity to prevent collapse under the pressure of the sides of an ocular incision.
U.S. Pat. No. 4,515,583 to Sorich discloses an improved ultrasonic surgical aspirator that discloses a first sleeve configuration made of a rigid material. Alternatively, the sleeve may be made of a resilient silicon rubber material and the ultrasonic surgical tool tip is configured to provide a space between the tip and sleeve when the resilient sleeve material is compressed by the ocular incision site. U.S. Pat. No. 4,808,154 to Freeman discloses another type of infusion sleeve that is designed to prevent collapse around an ultrasonic surgical tool tip. Herein, the infusion sleeve includes a plurality of ribs on the inner surface thereof to maintain irrigation fluid flow around the vibrating surgical tool tip.
In view of the above-mentioned prior art, a need has developed to provide an improved infusion sleeve that combines flexibility and rigidity to facilitate manipulation of a surgical tool as well as prevent damage to adjacent body tissue in the area of the surgical site.
In response to this need, an improved infusion sleeve has been developed which includes a flexible portion to permit retraction away from the operative tip of an ultrasonic surgical tool and a rigid portion which prevents blockage of irrigation fluid and subsequent overheating of the ultrasonic tool as well as damage to adjacent body tissue.